HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study (i-scan)
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|ClinicalTrials.gov Identifier: NCT02285426|
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment|
|Lungcancer||Device: Pentax EB-1990i HD-bronchoscope guided biopsy|
Patients will undergo a bronchoscopy with Pentax EB1990i HD-bronchoscope in combination with Pentax EPKi series videoprocessor investigating the entire bronchial tree. Bronchoscopy will be performed by an experienced chest physician under local anaesthesia use and type of sedation following local protocol. Bronchoscopy will be performed in a standardized order using three different imaging modes. The order of the different modes will be randomized to avoid induced scope and / or cough lesion bias. High definition digital videos will be made from all procedures without in screen patient identification, but using a study code. The three imaging modes used in this study are: HD+, HD+ surface enhancement (SE, i-scan1) and HD+ surface enhancement and tone enhancement (TE-c, i-scan2).
When sites with abnormal or suspicious vascular patterns are detected the investigator grade these findings using a visual classification scale [adapted from Herth JTO 2009 & Zaric Med Oncol 2013] and change to a regular bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control. Finally any other indicated procedures will be performed at the discretion of the local investigator.
|Study Type :||Observational|
|Actual Enrollment :||134 participants|
|Official Title:||A Multicenter Study Evaluating the Diagnostic Value for Vascular Abnormalities of High Definition Bronchoscopy When Combined With I-scan Imaging Technology Compared to High Defintion Bronchoscopy Alone|
|Actual Study Start Date :||October 20, 2014|
|Actual Primary Completion Date :||June 5, 2017|
|Actual Study Completion Date :||June 5, 2017|
Patients will undergo a bronchoscopy with the Pentax EB1990i HD-bronchoscope investigating the entire bronchial tree. The HD+ bronchoscopy needs to be performed in a standardized way using 3 different imaging modes:
Device: Pentax EB-1990i HD-bronchoscope guided biopsy
3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree.
When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality [visual scale adapted from Herth 2009 and Zaric 2013] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.
- positive predictive value of HD+ i-scan bronchoscopy for detecting (pre-) malignant lesions [ Time Frame: 7 days ]Determing the positive predictive value of HD+ i-scan bronchoscopy for vascular pattern detection .
- correlation between endobronchial vascular patterns and histology [ Time Frame: 7 days ]relate grading of detected vascular abnormalities with histology outcome of biopsies
- interobserver variability for detecting vascular abnormalities [ Time Frame: 3 - 12 months ]compare bronchoscopist reported outcome to central review of obtained videos to determine interobserver variability
- impact of HD-bronchoscopy on clinical decision [ Time Frame: 1-56 days ]interview based evaluation to investigate whether the use of of i-scan technology and or the outcome of study-detected vascular sites changed the clinical approach or follow-up plan
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285426
|Ospedale Umberto I, Via Dante Alighieri n.1|
|Ravenna, RA, Italy|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|St-Petersburg Research Institute of TB and Thoracic Surgery|
|Saint-Petersburg, Russian Federation|
|Hospital Universitario Santa Lucia|
|Murcia, Spain, 30202|
|Principal Investigator:||Erik HF van der Heijden, MD, PhD||Principal Investigator|